Pacemaker ImplantationNCT04842227
Blocks Alternative to Sedation
A study testing Nerve block in people with Pacemaker Implantation and ICD Implantation, run by Habib Khan at 1 site in Canada.
Trial summary
Current practice is to implant cardiac electronic devices using intravenous sedation with midazolam and fentanyl, as well as local injection of anesthetic (1-2). However, some patients do not tolerate sedation and develop nausea/vomiting, delirium/confusion, allergic reactions, and hemodynamic instability with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker Implantation, ICD Implantation
- What is being tested?
- Nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years old,
- Undergoing cardiac device implantation in the suprapectoral area of the chest.
Who cannot join
- Prior neck surgery ipsilateral to the device implantation site
- Infection over the injection site
- BMI ≥ 35
- Uncooperative patient
- Patient unable to provide consent
- Patient has a pre-existing implanted cardiac device in the left chest wall area
- Device implantation is booked in less than 2 hours.
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre Res. Inc. (Ont.)
London, Ontario, N6A 5A5
About this study
Official title: Regional Anesthesia for Cardiac Implantable Electronic Device Implantation
Current practice is to implant cardiac electronic devices using intravenous sedation with midazolam and fentanyl, as well as local injection of anesthetic (1-2). However, some patients do not tolerate sedation and develop nausea/vomiting, delirium/confusion, allergic reactions, and hemodynamic instability with sedation (2-4). Many patients are poor candidates for procedural sedation due to inadequate fasting before the procedure or prior adverse effects of procedural sedation. Pain control is usually adequate, but a large portion of patients still experience pain or discomfort at the implant site if the local anesthetic did not reach every component of the tissue in the surgical field. Meanwhile, nerve block procedures have been used for decades to improve peri-operative and post-operative pain and reduce sedation requirements. With the introduction of ultrasound, the investigators are able to direct delivery of local anesthetic to anesthetize the supraclavicular and pectoralis nerves that supply sensory/pain sensation to the surgical site. Similar techniques have been well described as safe and effective (5-10). The investigators hypothesize this will improve pain control during and after surgery, reduce or eliminate the need for intravenous sedation and improve the safety of the procedure.
Read the detailed description
Inpatients who are consented to have cardiac device implantation will be given study information as soon as the decision to implant a device is reached. The patients will have time to decide to participate in the study up until they are called for the procedure (2-72 hours, most commonly > 24 hours). The decision to participate in the study is conveyed to the investigator in the holding room, and written consent is obtained if the patient agrees to participate in the study.
The nerve block is performed in the holding room as a 2-step procedure by trained physicians.
After the nerve block approximately 30-60 minutes will be allowed for the anesthetic to take effect prior to the cardiac device implantation procedure. The patient will be monitored by the nurses in the holding room. Once the patient is taken to the operating room and prepped for the cardiac device implantation procedure, testing of the nerve blocks is performed. The superficial pin-prick test will be performed to determine the success of the SCN block, and a deeper test will be performed with a 22ga needle to ensure the deeper muscular layers are anesthetized and the PECs I block is successful. If both blocks are successful, the patient will receive optional light sedation with midazolam 0.01 mg/kg based on their preference, and the procedure can commence. If either the SCN or PECs blocks are not successful based on the sensation test, usual care is provided.
Immediately after the procedure, the patient is asked to rate the pain during the procedure on a numerical scale. Any adverse effects reported by the patient will be documented. The patient will then be reassessed 1 hour after the procedure in the holding room and then called the following day. One of the investigators will contact the patient by telephone on the following day (24hr later), and perform a similar assessment. The assessment will involve inquiring how the patient is feeling, documenting any unintended adverse effects, and asking the patient to rate their pain on a numerical scale.
- Conditions
- Pacemaker Implantation, ICD Implantation
- Being tested
- Nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve blockProcedure or surgery
Step 1: A small amount of local anesthetic (3-5cc of 0.5% ropivacaine) is administered under ultrasound guidance in the area of the supraclavicular nerve at the base of the neck under sterile conditions. This provides dense anesthesia of the skin and eliminates the need to introduce larger quantities of local anesthetic directly to the skin around the incision (usually 20mL).
The second step involves introducing 10-15cc of 0.5% ropivacaine under ultrasound guidance into the compartment between the pectoralis major and minor muscles to anesthetize the medial and lateral pectoral nerves. NOTE: Usual care involves "blind" administration of local anesthetic diffusely to the tissues in this region without targeting any particular nerves, and requires larger volumes of anesthetic (40mL for the "blind approach" vs 10-15mL for the nerve block).
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute anesthesia of skin and tissue
Needle prick test will be used over the subjected area to assess the nerve block. This will be measured as binary outcome (1-yes blocked ; 0 - not blocked). The region of anesthesia will also be measured by using an illustration to demarcate the region of block on the skin. The dermatomal distribution of the block will be measured in cm2.
Measured: 30 minutes after nerve block
Secondary outcomes (4)
Pain score
Pain score analog will be used to quantify the amount of pain during the procedure. Pain analog score is between 1-10 (1 being no pain to 10 being severe pain).
Measured: 0 hour of completion of device implant, 1 hour post procedure and 1 day post procedure.
IV sedation and pain
Quantify amounts(milligram) of additional sedation or pain relief required intravenously during the procedure
Measured: 0 hour
Duration of procedure
Quantify time required to complete the block
Measured: 0 hour
Safety of the nerve block
Any associated complications from the nerve blocks will be listed in a enumerated way and added together.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start1 May 2021
- Primary completion31 Dec 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pacemaker ImplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Habib Khan
- Sponsor type
- University, hospital or other
- Collaborators
- London Health Sciences Centre
- Responsible party
- Sponsor-investigator, Habib Khan, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842227
- Sponsor's protocol ID
- 10942
- Status last verified
- Apr 2022
- First submitted
- 8 Apr 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regional Anesthesia for Cardiac Implantable Electronic Device Implantation
- ClinicalTrials.gov ID
- NCT04842227
- Acronym / sponsor ID
- 10942
- Conditions
- Pacemaker Implantation, ICD Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Habib KhanUniversity, hospital or other
- Collaborators
- London Health Sciences Centre
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 13 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Current practice is to implant cardiac electronic devices using intravenous sedation with midazolam and fentanyl, as well as local injection of anesthetic (1-2). However, some patients do not tolerate sedation and develop nausea/vomiting, delirium/confusion, allergic reactions, and hemodynamic instability with sedation (2-4). Many patients are poor candidates for procedural sedation due to inadequate fasting before the procedure or prior adverse effects of procedural sedation. Pain control is usually adequate, but a large portion of patients still experience pain or discomfort at the implant site if the local anesthetic did not reach every component of the tissue in the surgical field. Meanwhile, nerve block procedures have been used for decades to improve peri-operative and post-operative pain and reduce sedation requirements. With the introduction of ultrasound, the investigators are able to direct delivery of local anesthetic to anesthetize the supraclavicular and pectoralis nerves that supply sensory/pain sensation to the surgical site. Similar techniques have been well described as safe and effective (5-10). The investigators hypothesize this will improve pain control during and after surgery, reduce or eliminate the need for intravenous sedation and improve the safety of the procedure.
Detailed description
Inpatients who are consented to have cardiac device implantation will be given study information as soon as the decision to implant a device is reached. The patients will have time to decide to participate in the study up until they are called for the procedure (2-72 hours, most commonly > 24 hours). The decision to participate in the study is conveyed to the investigator in the holding room, and written consent is obtained if the patient agrees to participate in the study.
The nerve block is performed in the holding room as a 2-step procedure by trained physicians.
After the nerve block approximately 30-60 minutes will be allowed for the anesthetic to take effect prior to the cardiac device implantation procedure. The patient will be monitored by the nurses in the holding room. Once the patient is taken to the operating room and prepped for the cardiac device implantation procedure, testing of the nerve blocks is performed. The superficial pin-prick test will be performed to determine the success of the SCN block, and a deeper test will be performed with a 22ga needle to ensure the deeper muscular layers are anesthetized and the PECs I block is successful. If both blocks are successful, the patient will receive optional light sedation with midazolam 0.01 mg/kg based on their preference, and the procedure can commence. If either the SCN or PECs blocks are not successful based on the sensation test, usual care is provided.
Immediately after the procedure, the patient is asked to rate the pain during the procedure on a numerical scale. Any adverse effects reported by the patient will be documented. The patient will then be reassessed 1 hour after the procedure in the holding room and then called the following day. One of the investigators will contact the patient by telephone on the following day (24hr later), and perform a similar assessment. The assessment will involve inquiring how the patient is feeling, documenting any unintended adverse effects, and asking the patient to rate their pain on a numerical scale.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- > 18 years old,
- Undergoing cardiac device implantation in the suprapectoral area of the chest.
Key exclusion criteria (7 listed)
- Prior neck surgery ipsilateral to the device implantation site
- Infection over the injection site
- BMI ≥ 35
- Uncooperative patient
- Patient unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nerve blockStep 1: A small amount of local anesthetic (3-5cc of 0.5% ropivacaine) is administered under ultrasound guidance in the area of the supraclavicular nerve at the base of the neck under sterile conditions. This provides dense anesthesia of the skin and eliminates the need to introduce larger quantities of local anesthetic directly to the skin around the incision (usually 20mL). The second step involves introducing 10-15cc of 0.5% ropivacaine under ultrasound guidance into the compartment between the pectoralis major and minor muscles to anesthetize the medial and lateral pectoral nerves. NOTE: Usual care involves "blind" administration of local anesthetic diffusely to the tissues in this region without targeting any particular nerves, and requires larger volumes of anesthetic (40mL for the "blind approach" vs 10-15mL for the nerve block). | Procedure or surgery | – |
Primary outcome
Acute anesthesia of skin and tissue
Time frame: 30 minutes after nerve block
Needle prick test will be used over the subjected area to assess the nerve block. This will be measured as binary outcome (1-yes blocked ; 0 - not blocked). The region of anesthesia will also be measured by using an illustration to demarcate the region of block on the skin. The dermatomal distribution of the block will be measured in cm2.
4 secondary outcomes
Pain score
Time frame: 0 hour of completion of device implant, 1 hour post procedure and 1 day post procedure.
IV sedation and pain
Time frame: 0 hour
Duration of procedure
Time frame: 0 hour
Safety of the nerve block
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve block in people with Pacemaker Implantation and ICD Implantation, run by Habib Khan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute anesthesia of skin and tissue (time frame: 30 minutes after nerve block). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022.